A. Field of the Invention
Many approaches have been made to the treatment of hemorhoids and rectal tissue following surgical procedures over the years with varying degrees of success in each case. One approach has been the use of a cold temperature rectal insert for treating the hemorrhoids and to promote healing process after surgery. It is to this field of invention that the present invention is desired.
B. Prior Art Found in the Field of the Invention
The closest prior art located in the field of the invention is described in U.S. Pat. No. 3,939,842 issued to A. M. Harris and in U.S. Pat. No. 4,563,182 issued to V. M. Stoy et al. The Harris patent discloses a unitary molded plastic rectal insert encapsulating a freezable liquid comprised of water, ethylene glycol, propylene glycol and mixtures thereof. The insert is fabricated from low density polyethylene tubing that is extruded with varying wall thicknesses and then blow molded, filled and then sealed.
The Stoy et al patent discloses a rectal insert comprised of a meltable hydrogel. The hydrogel contains from 35-90% water and is frozen into a desired rectal insert shape in a blister pack. Then the hydrogel insert is removed from the blister pack and inserted directly into the rectum. As body heat is conducted into the hydrogel, the hydrogel melts thereby losing its physical shape. The hydrogel is without physiological effect on the user.
Another patent, U.S. Pat. No. 3,885,403 issued to J. J. Spencer relates to a hot and cold compress which maintains its solid state, usually a frozen state, over a wide temperature range. This device is employed externally to contact the skin of the user and donate prolonged cold to the external area impacted. The pad is essentially a tough, flexible envelope containing a liquid or paste or gel which has a low freezing point and a high boiling point. The envelope contains a gelling agent such as carboxy vinyl polymer of high molecular weight, and a water/glycol mixture exhibiting freezing point depression characteristics. The envelope is used as a hot or cold compress to be laid flat against the skin of the user to heat or cool the external skin surface.
A problem associated with a one piece rectal insert containing a frozen liquid mixture comprised of toxic materials such as ethylene glycol and propylene glycol is that there is danger of causing injury to the user if the insert springs a leak.
Another problem associated with prior art rectal inserts is that they are sometimes difficult to remove after they have been in position for a period.
A problem associated with a rectal insert comprised of a hydrogel that melts in direct contact with body tissues is that the melted hydrogel creates an undesirable mess. Furthermore, as the hydrogel melts, it loses its physical shape causing an undesirable sensation of a rectal insert having a constantly changing shape and size.
There is a need for a simple rectal insert having provisions to avoid leaking of confined fluids. There is also a need for a rectal insert which provides for easy removal after use. There is a need for composition to act as precooling (frozen) media to provide/obtain sufficient period of cooling time.